The Pharma Marketing Glossary

Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas:

Ensuring that their companies comply with all of the regulations and laws pertaining to their business.

Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices).

Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.

Relationship Marketing

Use of various interactive media to develop, maintain, and foster a relationship with a current and prospective customer to maximize need satisfaction, share of mind and budget, and nurture loyalty and, ultimately, advocacy of the brand of a product or service.

Relationship or DR marketing is designed to achieve two-way dialogue with the prospect. The one-on-one nature of direct-response marketing is ultimately designed to affect behavior.

"Relationship marketing is permission-based. Communications are anticipated and relevant instead of random. Every communication asks for dialogue with respect. When permission is obtained, it creates a positive brand experience at every touch point.

Reminder advertisements are identified as an exemption to the advertisement regulations, including provisions to provide a brief summary. Reminder advertisements " . . . call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. . . . and, optionally, information . . . containing no representation or suggestion relating to the advertised drug product." Reminder advertisements cannot make a representation about the product or suggest a use for the product.

Reminder labeling is exempt from the requirements for adequate directions for use and adequate warnings. Reminder labeling, as defined in 21 CFR 201.100(f), is exempted. Reminder labeling calls attention to the name of the drug product but does not include indications or dosage recommendations for use. Reminder labeling may contain only the proprietary name of the drug, the established name of each active ingredient, and optionally, information relating to quantitative ingredient statements, dosage form, quantity of package contents, price, and other limited information.

The exemption does not apply to products with black box warnings in their approved product labeling.

REMS (Risk Evaluation and Mitigation Strategy)

In 2007, a new law that gave FDA many new authorities and responsibilities to enhance drug safety was enacted. It's called the Food and Drug Administration Amendments Act- sometimes called "FDAAA"- and one of its provisions gave FDA the authority to require a Risk Evaluation and Mitigation Strategy-(REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS.

A REMs may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. Since medicines are very different from each other, each REMS for each medicine is also different.

In a "reverse payment" agreement between a brand-name drug manufacturer and a potential generic competitor, a patent holder (the brand-name manufacturer) agrees to pay a large sum of money to an accused infringer (its would-be competitor), and the competitor agrees that it will no longer challenge the patent and will not enter the market for a specified period of time.Source:Petition for a Writ of Certiorari

Brand-name pharmaceutical companies can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time. These so-called "pay-for-delay" agreements have arisen as part of patent litigation settlement agreements between brand-name and generic pharmaceutical companies.

Pay-for-delay agreements appear in some settlements of patent litigation between brand-name and generic pharmaceutical companies. That patent litigation usually takes place within the framework for generic entry established by the Hatch-Waxman Act.

Under that Act, a generic competitor may seek entry prior to expiration of the patents on a brand-name drug. Generic drug entry before patent expiration can save consumers billions of dollars. Generics have an incentive to challenge brand patents because the first generic to file its application can obtain 180 days of marketing exclusivity during which it is the only generic on the market. To seek FDA approval for entry before patent expiration, a generic must declare that its product does not infringe the relevant patents or that the relevant patents are invalid. Typically, brand-name pharmaceutical companies challenge the generic's declaration, and litigation ensues between the brand-name and generic pharmaceutical manufacturers to determine whether the relevant patents are valid and infringed. For the brand to prevail and block entry, it must successfully defend the validity of its patents and demonstrate that the generic's product would infringe those patents. In 2002, the FTC issued a study showing that generics prevailed in 73% of the patent litigation ultimately resolved by a court decision between 1992 and June 2002.

Given the costs and potential uncertainty of patent litigation, brand-name and generic pharmaceutical companies sometimes settle their patent litigation before a final court decision. For example, the parties may agree that the generic can enter at some time before the patent's expiration date, but not as soon as the generic seeks through its litigation

POPULAR CATEGORY

The Pharma Marketing Network® was established in 2003 by John Mack (aka Pharmaguy). Our ongoing mission is to continue the work John started; speaking truth to power, asking tough questions, and building this ever-growing community of conscientious professionals.